FDA GRAS notification guide to dossiers and response letters
FDA GRAS notification uses a seven-part dossier. Learn who files, what evidence is needed, how review works and why no questions does not mean approval.
FDA GRAS notification tells FDA that a notifier has concluded a substance is generally recognized as safe for specified food uses. The process uses a seven-part notice, FDA review and a response letter, rather than a food-additive approval application. The notification rules set out that process.
Section 170.205 permits voluntary notification. FDA's GRAS program page describes an August 10, 2026 proposed rule seeking public feedback. A proposal is not an enacted filing mandate. Check FDA's current program information before making a submission decision.
Who can file a GRAS notice?
Any person may notify FDA, including a company or other legal entity. An attorney, agent or expert can prepare or submit the notice, but responsibility remains with the notifier. These roles are defined in sections 170.203 and 170.205.
Before preparing what people sometimes call a "GRAS application," define the substance and its intended uses. The dossier must address identity, manufacture, specifications, intended foods, use levels and dietary exposure. A substance name alone does not provide those details. See sections 170.225 through 170.235.
What evidence and GRAS testing do you need?
For the scientific-procedures route, the evidence must meet the same quantity and quality standard required for food-additive approval. General recognition rests on generally available and accepted scientific evidence or methods, ordinarily published. Unpublished information may corroborate that basis. Both safety and general recognition are required under section 170.30(b).
Neither that provision nor the notice requirements prescribes a universal set of tests. Nor do they require a separately commissioned expert panel for every ingredient. General recognition among qualified experts remains essential. A panel vote cannot replace an adequate evidence base, and the absence of a mandatory panel does not remove the need for safety evidence.
The alternative common-use route requires a substantial history of food consumption before January 1, 1958, with further requirements for foreign-use evidence. Recent sales alone do not establish that history under section 170.30.
Prepare all seven dossier parts
Put each part on separate pages or sets of pages. If a part does not apply, explain why instead of omitting it. The following checklist follows sections 170.220 through 170.255.
| Part | What to include |
|---|---|
| 1. Signed statements and certification | Identify the notifier, substance, intended foods, levels and purposes. State the GRAS basis and exemption conclusion. Address access to underlying information and disclosure. Certify a complete, representative and balanced submission, including unfavorable information. |
| 2. Identity, manufacture, specifications and technical effect | Describe the substance, relevant biological source and manufacturing process. Set food-grade specifications. Include technical-effect evidence where needed for safety. |
| 3. Dietary exposure | Estimate exposure from intended uses and all dietary sources. Address relevant reaction products, contaminants and by-products. Explain consumption data and assumptions. |
| 4. Self-limiting use levels | Where applicable, explain why higher levels would make food unpalatable or technologically impractical. |
| 5. Common use before 1958 | Provide evidence for this route, or explain why it does not apply when relying on scientific procedures. |
| 6. Safety and general-recognition narrative | Connect the evidence to the conclusion. Distinguish public from nonpublic information, discuss contrary evidence and identify specific confidentiality claims. |
| 7. Supporting-data list | List the evidence discussed in the narrative. Identify which information is generally available and which is not. |
Part 1 must be dated and signed by a responsible official, attorney or agent. Part 1 generally excludes trade secrets and confidential commercial information, apart from the specified disclosure-position statement. Dietary exposure applies under either evidentiary route. These requirements appear in sections 170.225 and 170.235.
Submit the notice and track the filing date
The regulation permits accessible electronic submission or a single paper copy. For operational instructions, use FDA's current GRAS page. It links "Providing Regulatory Submissions to OFAS" and the Centralized Online Submission Module. For Office of Food Additive Safety submission details, follow those current instructions rather than copying a legacy address.
FDA first decides whether to file the notice. It then communicates the filing date or its reasons for not filing. Filing is a procedural step, not substantive clearance, under section 170.265.
The response period starts at filing, not receipt. FDA must respond within 180 days and may extend that period by 90 days. It must notify the filer of an extension no later than day 180. There is no automatic approval when time passes, and this is not a guaranteed submission-to-response timetable. See section 170.265(b).
Before the response, you may amend the notice or request cessation of evaluation. A cessation request does not prevent a future notice under section 170.260.
Read the response letter and GRN record
FDA's program explanation describes three outcomes:
- FDA does not question the basis for the notifier's GRAS conclusion.
- The notice provides an insufficient basis for that conclusion.
- FDA ceases evaluation at the notifier's request.
A "no questions" letter concerns the notifier's conclusion. It is neither FDA affirmation of GRAS status nor food-additive approval, as the 2016 final-rule preamble explains. A ceased evaluation is not a favorable safety conclusion.
Use the GRAS Notice Inventory, or GRN inventory, to locate the record. Read the actual dossier and letter, matching the substance and intended uses. Do not treat an inventory entry as approval. Submitted information is available for disclosure subject to applicable exemptions under section 170.275, so do not assume the dossier will remain private.
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